One of the most established markets in today's medical field is the cosmetic surgery market. Every year, billions of dollars are spent by consumers on an assortment of body augmentations. This surgical rejuvenation fad first became popular back in the late 1990s. It was at this time that many biocompatible materials became widely available to surgeons for use in body augmentation procedures.
A very popular biocompatible material that has been used in the past is collagen. Collagen requires an allergy test by a patient since it is extracted from bovine hides. It may last anywhere from four to twelve weeks because it is also absorbed in to the body.
Autologen is an example of another biocompatible material that has been used in the past. It is an injectable dermal material made from a patient's own skin. There is not a risk of allergic reaction with autologen, however, the results stemming from surgery using autologen are very temporary because of the fact that the body quickly absorbs the material. Dermalogen is a filler taken from a patient's skin. Through a laboratory process, this filler is made into a high concentration collagen that can be injected. It has been studied that dermalogen may last somewhat longer than collagen. Another example of a filler is Alloderm® (a registered trademark of LifeCell Corporation). Alloderm® is a donor tissue taken from cadavers that is denatured, purified, and treated in order to remove viable cells that could pass along disease. It is a popular filler for lip injections. Under a local anesthesia, Alloderm® is placed into the mucosa, or body, of the lips in small rolls to make them larger. The filler may also be placed into the vermilion, the pink area of the lip, to provide definition and a sharper border. All of the fillers listed so far have been used in the past. More efficient fillers are used today.
The fillers used today may typically be divided into two categories: hyaluronic acids and “other fillers”. Hyaluronic acids can further be broken down into two categories: regular lasting and long lasting. The regular lasting category includes fillers such as Restylane, Juvederm Ultra, and Prevelle.
Restylane® (a registered trademark of Q-Med) is a filler recommended for patients with mild to moderate facial wrinkles and for patients who want softer lips. It is preferred that Restylane® be used on first time and/or younger patients. Restylane® lasts four to six months and is soft and easier to use than most other fillers. A second very popular regular filler is Juvederm Ultra® (a registered trademark of Allergan, Inc.). Juvederm Ultra® is similar to Restylane® in softness and is also preferred in younger patients and/or patients with mild to moderate wrinkles. Prevelle® (a registered trademark of Mentor Worldwide LLC) is a third very popular regular filler. It is similar to Restylane® and Juvederm Ultra® but is softer. Prevelle® is used for mild wrinkles and is good for the lips, but does not last as long as Restylane® or Juvederm Ultra®.
The group of longer lasting hyaluronic acids include Juvederm Ultra Plus® (a registered trademark of Allergan, Inc.) and Perlane® (a registered trademark of HA North American Sales AB). Juvederm Ultra Plus® lasts for eight to nine months or longer and is good for moderate to severe wrinkles. It is also thicker than Juvederm Ultra® and therefore requires more massage to assure there is no lumpiness in the treated area. Perlane® may last eight to nine months or longer and is good for moderate to severe wrinkles. It is also a thicker filler and therefore requires more massage around the treated area to assure there is no lumpiness.
The fillers that make up the “other fillers” category includes Radiesse® (a registered trademark of Merz Aesthetics), Sculptra® (a registered trademark of Valeant Pharmaceuticals International, Inc.), Artefill® (a registered trademark of Suneva Medical, Inc.), and fat. Radiesse® is a synthetic, laboratory produced solution containing calcium hydroxylapatite suspended in a gel. It is a biocompatible material that has been safely used in medicine for years. Studies have shown that Radiesse® can last between three and five years when used for bodily enhancement. The filler lasts nine months to a year and is very good for the treatment of severe wrinkles or areas that need a “firmer” filler to correct a defect such as an ear lobe, the nose, filling depressed scars, and the forehead. A massage of the treatment area is necessary after surgery in order to prevent nodules. Sculptra®, or poly-L-lactic acid) promotes collagen synthesis or remodeling. It has been used worldwide since 1999. Artefill® comprises polymethylmethacrylate (PMMA) microspheres and purified bovine collagen. Polymethylmethacrylate is a plastic compound that requires a patient to undergo allergy testing to make sure that they are not allergic to the compound. It has been used in medicine previously as a glue compound for hip prostheses. Claims have been made that Artefill® could last five years, but testing is still being done in order to prove that claim. Fat is a natural, non allergenic alternative to dermal fillers. It contains growth factors and stem cells that not only fill, but synthesize collagen and skin cells so that a patient's skin over the filled area even looks better. Fat may last two to four years or longer.
Another example of a biocompatible material is Gore-Tex® (a registered trademark of W.L. Gore & Associates) implants. Gore-Tex® is also referred to as EPTFE, or expanded polytetrafluoroethylene, in the medical field and Advanta™, Ultrasoft™, and SoftForm™ in the marketplace. The EPTFE that comprises Gore-Tex is delivered to surgeons in strips that are either 1/16 inch or 3/16 inch diameter tubes.
However, after injecting (or placing) the filler material in the patient, the filler must be shaped or formed to achieve the desired effect. Currently, there is not a well established tool for aiding in the manipulation of filler during cosmetic surgery. Doctors and clinicians today may use something similar to a Q-tip® (a registered trademark of Unilever). There are a number of different cosmetic surgeries that would benefit from a filler manipulator.
Periorbital surgery is one example of a surgery that would benefit from a filler manipulator. The periorbital is the area situated around the orbit of the eye. Periorbital soft tissues are easily contused and produce marked inflammatory responses to trauma. Because the cotton swab requires significant pressure and repeated strokes (e.g. passes over the skin to form the filler injected (or placed) below the skin) to properly form the filler, extensive contusions and inflammation are the norm.
The zygomatic arch is the arch formed by the processes of the zygomatic and temporal bones. It is the bone that forms the hard part of the cheek and the lower, lateral portion of the rim of the orbit. Surgery for this part of the body requires filler manipulation at a precise angle. Again, the use of cotton swabs to form filler in this area is inherently difficult and very time consuming because of the relatively sharp angles desired of the final product.
Rhinoplasty means nose molding or nose forming. It refers to a procedure in plastic surgery in which the structure of the nose is changed. These alterations may be made by adding or removing bone or cartilage, grafting tissue from another part of the body, or implanting synthetic material to alter the shape of the nose. If breathing is impaired due to the form of the nose or injury, using a non-surgical approach will help alleviate these symptoms only on a temporary basis (acts like a splint). A non-surgical approach, such as applying an implant/filler, is most often used for correction of a crooked nose, malformation at birth, or a deformity caused by an injury or cancer. The quality of the skin plays a major role in the outcome of both approaches.
Mandible is the medical term for the lower jaw, specifically, the horseshoe-shaped bone forming the lower jaw. It consists of a central portion, which forms the chin and supports the lower teeth, and perpendicular portions, or rami, which point upward from the back of the chin on either side and articulate with the temporal bones. Tense/rigid ligaments, tendons, and muscles pull the jaw bone long enough to cause displacements of the jaw and jaw pain. Having surgery or a non-surgical approach with a neurotoxin or filler will provide the patient relief in pain. The non-surgical approaches are great options for those who do not want surgery or those who are not candidates for surgery.
Large cavities and regions of the body can require a substantial amount of replacement filler. Parts of the body such as the buttocks, arm, leg, and abdominal region fall under this category. These areas may require a large amount of filler and therefore a lot of surgical attention.
Genitalia enhancements are another popular surgical procedure. This type of procedure involves the addition of very sensitive filler to the vaginal and penile regions. These areas also may also require a lot of surgical attention.
Accordingly, a need exists for cosmetic surgery tools that allow a patient a better outcome, less chance of an infection, and a quicker recovery time.